Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study evaluating ctx110 in subjects with relapsed or refractory b-cell malignancies (carbon)

Conditions: B-cell Malignancy; Non-Hodgkin Lymphoma; B-cell Lymphoma; Adult B Cell ALL

Summary: this is an open-label, multicenter, phase 1/2 study evaluating the safety and efficacy of ctx110 in subjects with relapsed or refractory b-cell malignancies.

the study may enroll up to 227 subjects in total. ctx110 is a cd19-directed chimeric antigen receptor (car) t cell immunotherapy comprised of allogeneic t cells prepared for the treatment of b cell malignancies. the cells are from healthy adult volunteer donors that are genetically modified ex vivo using crispr-cas9 (clustered regularly interspaced short palindromic repeats/ crispr-associated protein 9) gene editing components (single guide rna and cas9 nuclease).

Eligibility criteria:
key inclusion criteria: 1. for nhl patients: age ≥18 years. for b cell all patients: age ≥18 years to ≤70 years 2. refractory or relapsed non-hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed b cell all, refractory or relapsed. 3. eastern cooperative oncology group performance status 0 or 1. 4. adequate renal, liver, cardiac and pulmonary organ function 5. female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after ctx110 infusion. key exclusion criteria: 1. for nhl patients: prior allogeneic hsct. for b cell all patients: prior allogeneic hsct within 6 months, and/or any evidence of gvhd. 2. history of central nervous system (cns) involvement by malignancy 3. history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement. 4. presence of bacterial, viral, or fungal infection that is uncontrolled. 5. positive for hiv, or active hepatitis b virus or hepatitis c virus infection. 6. previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years. 7. for nhl patients: use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of ctx110 infusion. for b cell all patients: use of systemic antitumor therapy within 7 days of ctx110 infusion. 8. primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 9. women who are pregnant or breastfeeding.

Keywords: car t non-hodgkin lymphoma nhl lymphoma allogeneic leukemia
cerebral and circulatory effects of neonatal volume targeted ventilation

Conditions: Respiratory Distress Syndrome, Newborn; Respiratory Failure; Premature Birth

Summary: the aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (mv) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.

prospective, cross-over trial enrolling neonates \<28 weeks' gestation requiring mv. patients were ventilated for 3 hours with pressure controlled assist-control (pc-ac) mode, followed by 3-hours of volume guarantee assist-control ventilation (vg-ac). continuous monitoring was carried out using pulse oximetry (oxygen saturation - spo2 and heart rate - hr), near-infrared spectroscopy (cerebral oxygenation - sto2) and electrical cardiometry (circulatory parameters).

Eligibility criteria:
inclusion criteria: * premature infants born \<28 weeks of gestation * respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation * stable condition with ph (acidity of blood)\> 7.2 and pco2 (carbon dioxide partial pressure) \<60 mmhg in the blood gas analysis * no identified genetic syndromes and serious congenital malformations exclusion criteria: * lack of written consent of patients' parents
a new method of surgically treating varicose veins and venous ulcers - a study to assess clinical and economic value

Conditions: Varicose Veins; Venous Insufficiency; Venous Ulceration

Summary: varicose veins are a common problem, affecting up to a third of the western adult population. most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. this is known to have a significant negative effect on patient's quality of life (qol). surgery has been used for many years, but it is known that there is a temporary decline in qol post-op. this was demonstrated in our pilot study. surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury. recurrence rates are known to be significant. duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years. 26% of nhs patients were 'very dissatisfied' with their varicose vein surgery. newer, less invasive treatments are being developed. it would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. these should be the aims of any new treatment for varicose veins. endovenous laser treatment (evlt) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. the vein therefore need not be tied off surgically and stripped out. the aim of this study is to compare the clinical, cost effectiveness and safety of surgery and evlt.


Eligibility criteria:
inclusion criteria: * primary, symptomatic, varicose veins. * isolated saphenofemoral junction (sfj) incompetence leading to long saphenous (lsv) reflux on duplex ultrasound. * lsv of 4mm diameter at the knee. * ability to give informed written consent. exclusion criteria: * inability to give informed written consent. * symptomatic or complicated varicose veins not attributable to sfj/lsv reflux. * evidence of deep venous reflux on duplex scan.

Keywords: varicose veins chronic venous insufficiency venous ulceration surgery endovenous laser
a prospective, open, multicenter clinical trial of eltrombopag combined with diacerein in eltrombopag-inefficient or relapsed itp

Conditions: Thrombocytopenia

Summary: eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as second line therapy in itp patients. diacerein is a slow-acting medicine of the class anthraquinone used to treat joint diseases such as osteoarthritis. the project was undertaking by qilu hospital of shandong university and other 5 well-known hospitals in china. in order to report the efficacy and safety of eltrombopag combined with diacerein in the management of itp.

the investigators are undertaking a prospective, open, multicentre trial of 30 itp adult patients with eltrombopag-inefficient or relapsed from 6 medical centers in china. the initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. the dose of diacerein administration is 50 mg orally twice daily. the treatment was discontinued after 6 weeks without blood index reaction. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study. in order to report the efficacy and safety of eltrombopag combined with diacerein for the treatment of adults patients with eltrombopag-inefficient or relapsed.

Eligibility criteria:
inclusion criteria: * itp patients with eltrombopag-inefficient or relapsed need of treatment(s) to minimize the risk of clinically significant bleeding primary itp confirmed by excluding other supervened causes of thrombocytopenia exclusion criteria: * pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment hcv, hiv, hbsag seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Keywords: itp eltrombopag diacerein
shafer width and girth: the use of injectable fillers for penile enhancement

Conditions: Micropenis

Summary: injectable filler will be performed by principal investigator under sterile conditions for the enhancement of girth and surface area of the penis.


Eligibility criteria:
inclusion criteria: * healthy males, * 21 to 65 years of age, * seeking enhancement of their penile width and girth. exclusion criteria: * patient with a history of psychological or psychiatric illness, * congenital or acquired penile malformation, * previous plastic surgery or non-invasive treatments of their penis, * any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy. * patients with a history of allergic reactions to hyaluronic acid derivatives * individuals with penises measured less than 6 cm in length in the flaccid position * individuals with penises greater than 12.5 cm in length in the flaccid position. * individuals with uncircumcised penises
tolerance and compliance of a high caloric, high protein oral nutritional supplement - free intake

Conditions: Malnutrition

Summary: the aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ons) in elderly people


Eligibility criteria:
inclusion criteria: 1. sex: male/female 2. age: 65 years or older 3. body-mass index (bmi): ≥ 16.0 kg/m² and ≤ 30.0 kg/m² 4. subjects with an indication for ons of approx. 400 kcal per day for at least 7 days 5. written informed consent exclusion criteria: 1. existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition 2. subjects with galactosaemia or similar metabolic disorders 3. subjects with severely impaired gastrointestinal function or complete failure 4. subjects with insulin-requiring diabetes 5. subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day) 6. subjects reporting frequent occurrence of migraine attacks 7. subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia) 8. existing mouth abnormalities, which cause impaired gustatory sense 9. subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication) 10. subjects passing through chemotherapy (last cycle \< 2 months ago) 11. known allergic reactions or intolerance to any ingredient used or to constituents of the ons 12. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator 13. consumption of any additional ons, enteral nutrition via tube or parenteral nutrition 14. subjects with need of a special diet contradicting the intake of the ons 15. history of relevant central nervous system (cns) and/or psychiatric disorders and/or currently treated cns and/or psychiatric disorders 16. subjects with dysphagia or with high aspiration risk 17. enrolment in another clinical study 18. administration of any investigational medicinal product during the last month prior to individual enrolment of the subject 19. subjects who are not able to self-report gi-problems and compliance 20. subjects who report a general dislike of the ons flavour 21. subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned 22. subjects suspected or known not to follow instructions 23. subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study

Keywords: malnutrition geriatric subjects nursing home
uterine fibroid embolization- long term follow up and technical perspectives

Conditions: Uterine Fibroids; Arterial Embolization

Summary: the purpose of this prospective non-randomised study is to examine whether two different microspheres (bead-block and embosphere) are equally effective in the treatment of the uterine fibroid controlled with contrast-enhanced mr examination. quantitative mr imaging, including dominant fibroid t1, t2 and contrast enhancement characteristics before intervention and 3 months after interventions will be analysed as a potential predictor of volumetric response after embolization. another purpose is to determine long-term follow-up in all patient treated in a period from 2001-2011 in ouh analysed retrospectively.

group 1: 26 patient will be treated with bead-block microspheres - 700-900 µm microspheres or combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm microspheres until blood flow stop ( " cut the tree" appearance). group 2: 26 patient will be treated with embosphere; 500-900 µm until "near-stasis" flow stop in the uterine artery. clinical and technical success will be examined, and radiological follow-up 3 and 12 months after embolization using mr contrast-enhanced examination in a bead block group and only 3 months control in embosphere group to assess total fibroid burden infraction degree and eventually residual contracts fibroid enhancement. quantitative mri dominant fibroid characteristic for and 3 months after an intervention to examine eventually potential of as a possible predictor of the volumetric response of the uterine fibroid. retrospective study compromised all patient treated between january 2001 until january 2011 with follow up to january 2014, and re-intervention as well as complications rate analysis.

Eligibility criteria:
inclusion criteria: * symptomatic uterus fibroma exclusion criteria: * pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis) * gravidity * uterus malignancy * big subserosal fibroma with stalk diameter of \<2 cm * menopausal women * don,t want to be included into the study * concomitant adenomyosis
promoting recovery processes in women with borderline personality disorder using a dynamic cognitive intervention

Conditions: Borderline Personality Disorder

Summary: the field of psychiatric rehabilitation focuses on creating a personal narrative and developing coping strategies and environmental supports. the concept of recovery is person-centered and emphasizes the person's ability to change and to live meaningful life. the strengths approach has a central role in the recovery concept, emphasizing the person's abilities and potential. a preserved cognitive ability can be a significant strength in the recovery process. research had shown growing support for the use of cognitive-behavioral approaches as the most effective therapy for people with borderline personality disorder, using structured interventions. a central focus in cognitive therapy is the change of maladaptive schemes. the dynamic-cognitive intervention (dci) is based on the understanding of structural cognitive modifiability and suggests the use of mediated learning in order to enhance sense of competence and develop better psychological coping skills. the present study will focus on women diagnosed with borderline personality disorder, with normative cognitive ability seen as a strength as opposed to their emotional ability. this study will examine the effects of a dynamic cognitive intervention on recovery measures and on symptoms severity. the study will include 30 women aged 18-45 years. participants will be randomly assigned to an intervention group and a control group. all participants will be assessed before and after intervention using recovery assessment scale, hope scale and the brief symptom inventory. the intervention designed for this study is based on the principles of the dynamic cognitive intervention. the intervention tools that will be used include: a. instrumental enrichment tools. b. life events analysis. c. stories, lyrics and movie clips. d. worksheets. the intervention encompasses 12 sessions of 1.5 hours, with a routine structure. the results are expected to contribute to the understanding of the impact of a dynamic cognitive intervention in women diagnosed with borderline personality disorder.


Eligibility criteria:
inclusion criteria: * women * age 18 - 45 * borderline personality disorder, by dsm-v exclusion criteria: * current acute depressive episode * current psychotic episode * less than 12 school years * non compliance with therapy * dual diagnosis

Keywords: borderline personality disorder women dynamic cognitive intervention recovery hope scale
trail-running after knee or hip arthroplasty

Conditions: Arthropathy of Knee; Arthropathy of Hip

Summary: the incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy. in younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management. the repercussions of returning to sports after arthroplasty have been widely studied in the literature. few studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. the recommendations are essentially based on expert opinion.

the incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy. projections predict an increase in the number of prosthetic surgeries between 2020 and 2030 of 150% for total hip replacements (thr) and 230% for total knee replacements (tkr). in younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management. they are also more likely to resume physical activities with high peak joint stresses, known as "high-impact sports", most often against the advice of their surgeon. the repercussions of returning to sports after arthroplasty have been widely studied in the literature. these are essentially descriptive cross-sectional studies which show greater participation in low or medium impact sports activities in patients with prostheses. few studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. the recommendations are essentially based on expert opinion. concerning trail running, a discipline in full expansion, particularly in the longest formats; a single study in 2019, involving 18 runners with a prosthesis, did not reveal any specific constraints compared to healthy runners during a 170 km ultratrail.

Eligibility criteria:
inclusion criteria: * trail runner (declarative) * having been operated for a hip or knee arthroplasty * no limit to the length of time or volume of trail riding exclusion criteria: * refusal to participate * trailer not understanding french
ultrasound-guided genicular nerves block

Conditions: Genicular Nerve Block for Pain in ACL Arthroscopy

Summary: most of arthroscopic acl repairs are day case surgeries associated with moderate postoperative pain and discomfort. so , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay. in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (rom) after arthroscopic acl cases.

in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (rom) after arthroscopic acl cases.

Eligibility criteria:
inclusion criteria: * both genders * age 18 - 65 * asa i, ii, iii exclusion criteria: * rom less than 90 * advanced renal or liver diseases * patient refusal * substance abuse * site infection * known sensitivity to any of study drugs
wheelchair indoors curling with sci patients_rct

Conditions: Spinal Cord Injury

Summary: this study investigates if, patients with diagnosed chronic spinal cord injury will benefit from an indoor curling exercise program on their control capabilities of trunk movements and on their intrinsic motivation for physical activity. half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.

spinal cord injury (sci) is a catastrophic event that can be devastating and costly in human and social terms. these patients require multidisciplinary and interdisciplinary treatment. physiotherapy is important factor in sci rehabilitation. the objectives of physiotherapists are manifold and include the development of the force of healthy muscles, the teaching of transfer techniques, the maintenance of joint motion and of the body map, and the reestablishment of sitting balance in order for the patients to regain their autonomy. maintaining postural stability when seated is a challenge for people with a sci as their sensory and motor systems in their trunk, lower and upper extremities have been damaged to different degrees. to train this postural stability, physiotherapists include many interventions. physical activities in sport therapy are some of them. in addition to usual physical activities (basketball, tennis, wheelchair running,...) the investigators propose to practice wheelchair indoors curling exercise with wooden curling stones.

Eligibility criteria:
inclusion criteria: * traumatic, non-traumatic or ischemic spinal cord injury with complete or incomplete para- or tetraplegia * complete spinal cord status (asia score) * sitting capabilities ≥ 4 hours * capability to bench 20° forward in trunk flexion * signed informed consent after being informed exclusion criteria: * progressives pathologies * problem in vestibular system * severely impaired vision * tetraplegia without hand function * acute pain * contraindications on ethical grounds * previously reduced capabilities of cooperation * know or suspected non-compliance

Keywords: core stability indoors curling exercises motivation
bpa levels relationship with ivf/icsi outcomes in unexplained infertility

Conditions: Infertility Unexplained; IVF; Infertility, Female

Summary: the relationship between bpa elevation in urine, blood, and follicle fluid and embryo quality, ivf/icsi outcomes.


Eligibility criteria:
inclusion criteria: * patients aged 23-33 years who underwent ivf due to unexplained infertility * patients provided urine, blood, and follicle fluid (ff) samples on the oocyte retrieval day * patients who did not smoke or use alcohol * patients did not work in the plastic industry exclusion criteria: * patients who underwent ivf due to low ovarian reserve or tubal factor or male factor indications * patients diagnosed with endometriosis * patients with freeze-all cycles * women with metabolic disease (such as hypertension or diabetes mellitus) * patients with a known genetic problem (male or female)